Conventional vs Digital CAD/CAM Splints for Bruxism

June 9, 2025 updated by: Pontificia Universidade Católica do Rio Grande do Sul

Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints (Michigan Type) Versus CAD/CAM Splints With Fully Digital Flow

This is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. Participants will be randomized to receive either a conventional stabilization splint or a CAD/CAM splint. Each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. The study aims to compare the quality, precision, and comfort of the two types of occlusal splints. Outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90619-900
        • Faculdade de Odontologia. Pontifícia Universidade Católica do Rio Grande do Sul.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged between 20 and 55 years.
  • Probable or confirmed diagnosis of sleep bruxism.
  • No previous treatment with occlusal splints.
  • Absence of periodontal diseases and/or dental fractures.
  • Patients must have a minimum of 28 teeth.

Exclusion Criteria:

  • Patients with systemic diseases affecting the temporomandibular joint, such as rheumatoid arthritis, osteoarthritis, and osteoporosis.
  • Chronic users of medications that may interfere with the study results, including analgesics, anti-inflammatory drugs, anxiolytics, antidepressants, and anticonvulsants.
  • Patients with a history of temporomandibular joint surgery.
  • Pregnant or breastfeeding women.
  • Patients with severe dental misalignment or malocclusion that would affect splint fitting and evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital occlusal splints (CAD/CAM)

Patients in this arm will receive a CAD/CAM occlusal stabilization splint created using a fully digital workflow. The process includes:

  1. Digital Impression: digital scan of the mouth will be performed using a 3shape® intraoral scanner.
  2. Digital Design: The scanned data will be processed using Dental Wings' DWOS® software to design the occlusal splint virtually. The design will ensure the splint follows the Michigan splint type specifications.
  3. Manufacturing: The designed splint will be fabricated using a Straumann® P series rapidshape P30+ 3D printer with a specific acrylic resin, Cosmos Splint. The splint will be polished to ensure comfort and fit, while maintaining the same surface texture as the conventional splint.
  4. Fitting and Adjustment: The digitally fabricated splint will be fitted and adjusted as necessary to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process.
Device: Digital occlusal splints (CAD/CAM)
Consists of occlusal stabilization intra-oral splints fabricated using a fully digital workflow, involving intraoral scanning, virtual design, and 3D printing to ensure precise fit and comfort.
Other Names:
  • Digital intra-oral device
Active Comparator: Conventional occlusal splints

Patients in this arm will receive a conventional occlusal stabilization splint fabricated using traditional analog methods. The process includes:

  1. Impression Taking: Impressions of the patient's upper and lower arches will be taken using alginate.
  2. Model Preparation: The plaster models will be mounted on a semi-adjustable articulator using a centric relation occlusal record. A wax-up of the occlusal splint will be created following the Michigan splint type specifications.
  3. Manufacturing: The wax-up will be processed and flasked with heat-cured acrylic resin to create the final splint. The splint will be polished similarly to the digital splint to ensure a consistent appearance and texture.
  4. Fitting and Adjustment: The conventional splint will be fitted and adjusted to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process.
Device: Conventional occlusal splints
Consists of occlusal stabilization splints fabricated using traditional analog methods, including physical impressions, plaster models, and manual processing with heat-cured acrylic resin to achieve the desired occlusal arrangement.
Other Names:
  • Conventional intra-oral device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of occlusal contacts
Time Frame: Immediately after the initial installation
The number of occlusal contacts will be measured using the OccluSense® device
Immediately after the initial installation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Required for Splint Adjustment
Time Frame: Immediately after the initial installation and adjustment
The time required to adjust each splint during the fitting process
Immediately after the initial installation and adjustment
Participant satisfaction after installation
Time Frame: Immediately after the initial installation and adjustment
Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction.
Immediately after the initial installation and adjustment
Participant satisfaction after 30 days
Time Frame: After 30 days of use
Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction.
After 30 days of use
Splint comfort after installation
Time Frame: Immediately after the initial installation and adjustment
Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort.
Immediately after the initial installation and adjustment
Splint comfort after 30 days
Time Frame: After 30 days of use
Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort.
After 30 days of use
Splint stability after installation
Time Frame: Immediately after the initial installation and adjustment
Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement).
Immediately after the initial installation and adjustment
Splint stability after 30 days
Time Frame: After 30 days of use
Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement).
After 30 days of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Investigators

  • Study Chair: Marcio L Grossi, PhD, Pontificia Universidade Católica do Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59319422.3.0000.5336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned. Sharing of anonymized data may be considered under exceptional circumstances through direct contact with investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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